Relación entre el Finnish Diabetes Risk Score, glucemia en ayunas y hemoglobina A1c / Relationship between the Finnish Diabetes Risk Score, fasting blood glucose and glycohemoglobin A1c

Introducción: el Finnish Diabetes Risk Score (FINDRISC) mostró alta sensibilidad y especificidad para la detección de personas que evolucionarían a diabetes mellitus (DM) en las poblaciones estudiadas, por lo cual se decidió utilizarlo entre quienes concurrieron por diferentes motivos a realizarse análisis de laboratorio en centros de la Asociación de Laboratorios de Alta Complejidad (ALAC), con el objeto de identificar personas con diferentes niveles de riesgo de presentar alteraciones de la glucemia en ayunas (GA) y de la HbA1c. Objetivos: explorar la asociación entre la puntuación del FINDRISC con GA y HbA1c, estableciendo el punto de corte de mayor sensibilidad y especificidad para encontrar una GA ≥100 mg/dL y una HbA1c ≥5,7% (38,8 mmol/mol), en una población que concurrió a centros de la ALAC. Materiales y métodos: se incluyeron 1.175 individuos de 45 laboratorios de la ALAC, procesamiento local de glucemia y centralizado de HbA1c (high performance liquid chromatography, HPLC). Análisis estadístico: chi-cuadrado, Odds Ratio, ANOVA, test de Tukey, regresión logística binomial y curvas ROC. Resultados: los puntajes totales del FINDRISC se asociaron de manera positiva y estadísticamente significativa, tanto con los valores de GA como con los niveles de HbA1c. Entre sus variables, una edad mayor o igual a 45 años, un perímetro abdominal de alto riesgo, un índice de masa corporal mayor o igual a 25 Kg/m., la presencia de antecedentes familiares de DM (padres, hermanos o hijos) y la existencia de antecedentes de medicación antihipertensiva se asociaron de manera significativa con valores de GA iguales o superiores a 100 mg/dL y/o niveles de HbA1c iguales o mayores a 5,7% (38,8 mmol/mol). No se halló asociación significativa con la realización de actividad física (al menos 30 minutos diarios) ni con el registro de ingesta diario de frutas y verduras. Los valores medios de GA y HbA1c en individuos con puntajes totales del FINDRISC menores o iguales a 11 fueron de 89,9 mg/dL y 5,2% (33,0 mmol/mol), respectivamente, elevándose hasta valores medios de 116,1 mg/dL y 6,1% (43,0 mmol/mol) en los individuos con puntajes iguales o superiores a 21, siguiendo una asociación del tipo "dosis/respuesta". Por curvas ROC, un FINDRISC de 13 presenta una sensibilidad del 81,89%, especificidad del 67,60% y 70,55% de diagnósticos correctos de HbA1c ≥5,7% (38,8 mmol/mol), y una sensibilidad del 72,50%, especificidad del 70,62% y 71,20% de diagnósticos correctos para encontrar personas con una GA ≥100 mg/dL. Conclusiones: el puntaje del FINDRISC se relacionó con niveles crecientes de GA y HbA1c, resultando útil para encontrar personas con GA ≥100 mg/dL y HbA1c ≥5,7% (38,8 mmol/mol) en la población estudiada.

Introduction: the Finnish Diabetes Risk Score (FINDRISC) has high sensitivity and specificity for the identification of people at risk of diabetes mellitus (DM) in various populations. Therefore, we aimed to use this index to identify individuals at risk of having alterations in fasting glycemia (FG) and HbA1c among those who underwent laboratory analysis at ALAC, Argentina. Objectives: to explore the relationships of the FINDRISC score with the fasting blood glucose (FG) concentration and glycated hemoglobin (HbA1c) level, and to establish appropriate cut-off scores to predict FG ≥100 mg/dL and HbA1c ≥5.7% (38.8 mmol/mol) in this population. Materials and methods: we recruited 1,175 individuals from 45 ALAC laboratories for whom FG and HbA1c had been measured. We analyzed the data using the chi square test, odds ratios, ANOVA plus Tukey's post-hoc test, binomial logistic regression, and receiver operating characteristic (ROC) curves. Results: total FINDRISC score significantly positively correlated with both FG and HbA1c. Of the constituent variables, age ≥45 years, a large waist circumference, a body mass index ≥25 kg/m., a close family history of DM, and the use of antihypertensive medication were significantly associated with FG ≥100 mg/dL and/or HbA1c ≥5.7% (38.8 mmol/mol). However, no significant association was found with physical activity or the daily consumption of fruit and vegetables. The mean FG and HbA1c for individuals with total FINDRISC scores ≤11 were 89.9 mg/dL and 5.2% (33.0 mmol/mol), respectively, which increased to 116.1 mg/dL and 6.1% (43.0 mmol/mol) for individuals with scores ≥21, with a dose/response-type relationship. ROC analysis showed that a FINDRISC of 13 was associated with a sensitivity of 81.89%, a specificity of 67.60%, and a correct diagnosis rate of 70.55% for HbA1c ≥5.7% (38.8 mmol/mol); and a sensitivity of 72.50%, a specificity of 70.62%, and a correct diagnosis rate of 71.20% for FG ≥100 mg/dL. Conclusions: FINDRISC score increases with increasing FG and HbA1c, and is a useful means of identifying people with FG ≥100 mg/dL and HbA1c ≥5.7% (38.8 mmol/mol).

Glucemia en ayunas entre 100 y 109 mg/dL versus prediabetes según hemoglobina glicosilada / Fasting blood glucose between 100 and 109 mg/dL versus prediabetes according to glycosylated hemoglobin

Introducción: algunos estudios han señalado que valores de glucemia en ayunas entre 100 y 109 mg/dL se asocian con frecuencias elevadas de prediabetes cuando el criterio de clasificación son los valores de HbA1c. La Sociedad Argentina de Diabetes (SAD) sostiene a 110 mg/dL como valor a partir del cual se clasifica a un paciente como portador de glucemia en ayunas alterada; la frecuencia de individuos posiblemente clasificados en forma incorrecta, según este criterio, aún no se conoce en la población argentina. Objetivos: establecer la frecuencia con que se presenta prediabetes según HbA1c en una población sin diagnóstico de diabetes mellitus (DM) con glucemias en ayunas entre 100 y 109 mg/dL; correlacionar las dos variables y cuantificar la probabilidad de que esto ocurra respecto de otros con glucemias en ayunas <100 mg/dL. Materiales y métodos: se incluyeron 1.002 muestras de igual número de sujetos desde 45 laboratorios de análisis clínicos de la Asociación de Laboratorios de Alta Complejidad (ALAC), con procesamiento local de glucemia y centralizado de HbA1c por high performance liquid chromatography (HPLC). Análisis estadístico: chi cuadrado, odds ratio, coeficiente de correlación y determinación de Pearson, y correlación serial de Durbin-Watson. Resultados: frecuencia de HbA1c ≥5,7% en la población estudiada con glucemias de ayunas entre 100 y 109 mg/dL=29,7%; test de chi cuadrado: p<0,001; odds ratio de tener HbA1c ≥5,7% entre la población con glucemias en ayunas de 100 a 109 mg/dL vs aquella con valores <100 mg/dL=4,328 (IC 95% 2,922-6,411); r=0,852, r2 = 0,727, Durbin-Watson=1,152. Conclusiones: la prediabetes diagnosticada por HbA1c resultó cuatro veces más frecuente en la población estudiada con glucemias en ayunas entre 100 y 109 mg/dL, que en aquella con valores por debajo de 100 mg/dL.

Introduction: some studies have shown that fasting blood glucose values between 100 and 109 mg/dL are associated with high rates of prediabetes when the classification criteria are HbA1c values. The Argentine Diabetes Society still maintains 110 mg/dL as the value from which a patient is classified as having impaired fasting blood glucose; the frequency of individuals possibly incorrectly classified, according to this criterion, is not yet known in any Argentine population. Objectives: to establish the frequency in a population without a diagnosis of diabetes mellitus with fasting blood glucose levels between 100 and 109 mg/dL in which prediabetes occurs according to HbA1c, to correlate both variables and to quantify the probability that this predicts with respect to others with fasting blood glucose levels <100 mg/dL. Materials and methods: 1.002 samples from the same number of subjects from 45 clinical laboratories belonging to ALAC, with local processing of blood glucose and centralized processing of HbA1c by high performance liquid chromatography (HPLC). Statistical analysis: chi square, odds ratio, Pearson correlation coefficient, coefficient of determination and Durbin-Watson serial correlation. Results: frequency of HbA1c ≥5.7% in the studied population with fasting blood glucose levels between 100 and 109 mg/ dL = 29.7%, chi square test: p<0.001; odds ratio of having HbA1c ≥5.7% between the population with fasting blood glucose levels of 100 to 109 mg/dL vs that one with values <100 mg/dL=4.328 (95% CI 2.922-6.411); r=0.852, r2 =0.727, DurbinWatson=1.152. Conclusions: prediabetes diagnosed by HbA1c was four times more frequent in the studied population with fasting glucose values between 100 and 109 mg/dL than in that one with values below 100 mg/dL.

Glycated Hemoglobin Measurement: Comparison of Three Methods Versus High Performance Liquid Chromatography.

BACKGROUND: HbA1c result provide information on metabolic control in diabetes mellitus (DM) and could also be used for its diagnosis. For its determination, the laboratory must be certified by the National Glycohemoglobin Standardization Program (NGSP) or the International Federation of Clinical Chemistry (IFCC) and comply with a strict quality control program. AIMS: To determine the correlation and agreement between HbA1c results measured by three analytical methods (enzymatic, turbidimetric, and capillary electrophoresis) versus HPLC. METHODS: Method comparison-1245 samples from equal number of subjects at 45 Association of High Complexity Laboratories (Asociación de Laboratorios de Alta Complejidad-ALAC) centers, centralizing sample processing and operator. Statistical analysis-analysis of variance (ANOVA) and nonparametric Friedman ANOVA test for related samples, means, and medians. Correlation and concordance-Pearson's correlation and linear regression, intraclass correlation coefficient (Passing and Bablock and Bland and Altman). RESULTS: The comparison of mean values obtained by the four methods showed statistically significant, but clinically irrelevant, differences: HbA1c by HPLC versus Electrophoresis 0.06% (0.42 mmol/mol) P = .000 (± 1.96 DS -0.070 -0.047), Enzymatic 0.087% (1 mmol/mol) P = .000 (± 1.96 DS 0.077 0.098), Turbidimetric 0.056% (0.38 mmol/mol) P = 0.000 (± 1.96 DS -0.067 -0.044). Their concordance showed intraclass correlation of single measures of 0.982 P < .001 (95% CI 0.987 - 0.9838). CONCLUSIONS: The three methods present low variability and high correlation versus the HPLC.

Serum concentration of 17α-hydroxyprogesterone in children from birth to adolescence.

BACKGROUND: Reference intervals (RI) of serum 17α- hydroxyprogesterone (17OHP) are useful to confirm congenital adrenal hyperplasia (CAH) in neonates with abnormal screening results and nonclassical forms of CAH in symptomatic children. We aimed to establish serum 17OHP RI in normal children and adolescents using a current 17OHP radioimmunoassay (RIA). METHODS: Serum 17OHP was measured via a current RIA (Diasource) in children, i.e. 111 infants aged <1 year [before (NE-17OHP) and after extraction (E-17OHP)] and 216 children aged 1-17 years. Forty NE serum samples from subjects aged >1 year, covering the whole analytical range, were simultaneously measured to compare 17OHP RIA from Diagnostic System Laboratories (DSL) (withdrawn) and Diasource by Passing Bablok linear regression and ratio plot. The equation obtained was used to correct our own previous RI (DSL RIA) for infancy for the Diasource RIA. Samples from infants aged <1 year were used to verify the calculated RI with evaluator protocol C28-A3. The influence of age, gender, and Tanner's classification (T) was assessed in children aged >1 year by ANOVA. RESULTS: E-17OHP as measured via the Diasource RIA was significantly lower than NE-17OHP in infants aged <1 year (p < 0.0001). The 17OHP measurement from the Diasource RIA was negatively biased compared to the value obtained using the DSL RIA (Diasource (ng/ml) = 0.85 DSL (ng/ml) -0.32 ng/ml, r = 0.952). Most infants (93%) had age- and gender-adjusted NE-17OHP and E-17OHP levels within the recalculated RI. Serum 17OHP significantly increased throughout prepuberty (p < 0.001). Sexual dimorphism was only observed at T IV-V. CONCLUSION: When evaluating 17OHP during childhood, we recommend taking into account the extraction procedure in neonates, the method used, age, and the Tanner's stage.